Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
candesartan cilexetil, Quantity: 8 mg
Arrotex Pharmaceuticals Pty Ltd
Candesartan cilexetil
Tablet, uncoated
Excipient Ingredients: magnesium stearate; carmellose calcium; hyprolose; macrogol 8000; maize starch; lactose monohydrate; iron oxide red
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of hypertension.,Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction <=40percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Visual Identification: Light pink, round, biconvex uncoated mottled tablets debossed with 292 on one side and break line on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-05-02
Page 1 of 5 CANDESAN – Consumer Medicine Information CANDESAN _contains the active ingredient candesartan cilexetil _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CANDESAN. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking CANDESAN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT CANDESAN IS USED FOR CANDESAN belongs to a group of medicines known as angiotensin-II receptor antagonists (or blocker). CANDESAN is used to treat: • high blood pressure, also called hypertension • heart failure, usually in combination with other medicines to treat your condition. HYPERTENSION Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy you are or how you are feeling. You have hypertension (high blood pressure) which means your blood pressure stays high, even when you are calm and relaxed. Regular blood pressure checks are the only way of knowing that you have hypertension. There are usually no symptoms of hypertension and you may feel fine. If hypertension is not treated, serious health problems such as stroke or heart attack and heart or kidney failure may occur. CANDESAN lowers blood pressure by dilating (expanding) small blood vessels from the heart, letting the blood be pumped around the body more easily. HEART FAILURE Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not mean that the heart stops working. Heart failure may start off with no symptoms, but as the condition progresses, patie Read the complete document
Candesan PI 1 AUSTRALIAN PI CANDESAN (CANDESARTAN CILEXETIL) TABLETS 1 NAME OF THE MEDICINE _Candesartan cilexetil_ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CANDESAN tablets come in four strengths and contain 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil. EXCIPIENTS WITH KNOWN EFFECT Sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM _CANDESAN Candesartan cilexetil 4 mg tablet; _ Light pink, mottled, round biconvex uncoated tablet with ‘291’ on one side and a scoreline on the other side. _CANDESAN Candesartan cilexetil 8 mg tablet;_ Light pink, mottled, round biconvex uncoated tablet with ‘292’ on one side and a scoreline on the other side. _CANDESAN Candesartan cilexetil 16 mg tablet;_ Light pink, mottled, round biconvex uncoated tablet with ‘L293’ on one side and a scoreline on the other side. _CANDESAN Candesartan cilexetil 32 mg tablet;_ Light pink, mottled, round biconvex uncoated tablet with ‘L294’ on one side and a scoreline on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of hypertension. Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated. Candesan PI 2 4.2 D OSE AND METHOD OF ADMINISTRATION CANDESAN should be taken once daily with or without food. HYPERTENSION The recommended maintenance dose of candesartan is 8 mg or 16 mg once daily. The maximal antihypertensive effect is attained within 4 weeks following initiation of treatment. For those patients who start on 8 mg and require further blood pressure reduction, a dose increase to 16 mg is recommended. An initial dose of 16 mg is also well tolerated. Some patients may receive an additional benefit by increasing the dose to 32 mg once daily. In patients with less than optimal blood pressure reduction on candesartan, combination with a thiazide diuretic is recommended. _SPECIAL PATIENT Read the complete document